Adult Stem Cell Clinical Trial for patients with Critical Limb Ischemia (CLI) Caused by Severe Peripheral Arterial Disease (PAD)
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A Phase III clinical trial to evaluate the safety and efficacy of concentrated bone marrow aspirate to prevent or delay major amputation and/or death in patients with critical limb ischemia (CLI) caused by severe peripheral arterial disease (PAD)
Where?
- The University of Alabama at Birmingham
- Banner Heart Hospital, Mesa, Arizona
- Central Arkansas Veterans healthcare System, Little Rock, Arkansas
- University of California-Davis, Sacramento, California
- Indiana University School of Medicine, Indianapolis, Indiana
- University of Louisville, Louisville, Kentucky
- The Cleveland Clinic, Cleveland, Ohio
- Austin Heart Hospital, Austin, Texas
- University of North Texas Health Science Center at Fort Worth, Fort Worth, Texas
Why?:
The strategy being investigated is designed to improve blood flow in legs with blocked arteries by treating the diseased blood vessels. Because of the location and extent of the blockages in certain patients, standard treatments such as surgical bypass (insertion of a vein or synthetic graft to redirect blood flow around the blockage) and angioplasty (insertion of a balloon through the artery to open the blockage) will not improve blood flow to the leg, and amputation is the only alternative.
How?:
Bone marrow aspirate is obtained from the patient's hip, concentrated and injected intramuscularly to the affected limb. Patients who meet the inclusion/exclusion criteria will be randomized to receive either the investigational treatment or a placebo control.
When?:
June 2010 - October 2012
Duration: 52 weeks
To participate you must meet the following criteria:
- 21 years of age or older
- Lower extremity ischemia due to advanced peripheral arterial disease
- Non-candidate for surgical bypass or percutaneous angioplasty and stenting
You are not eligible to participate if you have any of the following:
- Existing malignant disease diagnosis
- Major tissue loss
- Poorly controlled diabetes
- Conditions that preclude general anesthesia
- Myocardial infarction or stroke within last 90 days
- Conditions that impair cognitive function
- Amputation required within 30 days
- Inclusion in any other clinical study that may affect the outcome of this study
- A study physician will go over additional exclusion criteria with you.
For More Information Contact:
Alabama
The University of Alabama at Birmingham
Contact: Donna Kerns,
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, (205) 934-7279
Arizona
Banner Heart Hospital, Mesa, Arizona
Contact: Heidi Terry,
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, (480) 854-5077
Arkansas
Central Arkansas Veterans Healthcare System, Little Rock, Arkansas
Contact: Sandra Brock,
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, (501) 257-6906
California
University of California-Davis Medical Center, Sacramento, California
Contact: Christy Pifer, (916) 734-4156
Indiana
Indiana University School of Medicine, Indianapolis, IN
Contact: Pat G'Sell,
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, (317) 278-6585
Kentucky
University of Louisville, Louisville, Kentucky
Contact: Jeanine L. Fell,
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, (502) 852-5895
Ohio
The Cleveland Clinic, Cleveland, Ohio
Contact: Shelley Carroscia,
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; (216) 444-0922
Texas
Austin Heart Hospital, Austin, Texas
Contact: Paige Musick,
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, (512) 421-3896
University of North Texas Health Science Center at Fort Worth
Contact: Bonnie Wicklund,
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, (817) 735-0304
